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Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis, NAFLD, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LiverMultiScan
Sponsored by
Perspectum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients aged 18-75 years, due to undergo evaluation for suspected non-alcoholic fatty liver disease

  • Presence of:

    • elevated liver function tests (ALT, AST or GGT ≥ 1.5 x upper limit of normal and ≤ 5 x upper limit of normal)

OR

  • imaging suggestive of Fatty liver disease.

OR

Presence of ≥ 3 of the following criteria:

  1. insulin resistance or type 2 diabetes mellitus
  2. obesity (BMI > 30 or waist-to-hip ratio > 1.00 for men / > 0.85 for women)
  3. hypertension (≥ 130/85 mmHg)
  4. elevated triglycerides (≥ 1.7 mmol/l)

  5. low HDL-cholesterol (< 1.05 mmol/l for men / < 1.25 mmol/l for women)

    • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
  • Patients with proven liver disease other than NAFLD.
  • Liver transplantation
  • Patients that present with clinical signs of chronic liver failure (variceal bleeding, ascites, overt encephalopathy)
  • Pregnancy
  • Alcohol over-use/ abuse as determined by local guidelines
  • Patient with known malignant liver tumours and those with any malignancy with life expectancy < 36 months
  • Heart failure NYHA stages II-IV
  • Severe mental illness
  • Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Sites / Locations

  • University Hospital Ulm
  • Leiden University Medical Center
  • University of Coimbra
  • Southampton University Hospital
  • Aintree Hospital
  • Ninewells Hospital
  • Royal Infirmary of Edinburgh
  • Glasgow Royal Infirmary
  • Queen Elizabeth University Hospital
  • King's College Hospital
  • St George's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Arm-LiverMultiScan

Control Arm

Arm Description

Patients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan.

Standard of care as per guidelines of the local centre

Outcomes

Primary Outcome Measures

To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost-effective method in different EU territories.
Proportion of patients with suspected NAFLD incurring liver related hospital consultations and/or liver biopsies, from the date of randomisation to the end of the study follow-up.

Secondary Outcome Measures

Patient satisfaction: questionnaire
Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study.
Certainty of diagnosis
Certainty of diagnosis is defined as binary (yes/no vs. unlikely/probable) at baseline and all follow-up visits to the end of the study.
Frequency of diagnosis
Frequency of diagnosis is defined as binary (yes/probable vs. no/unlikely) at baseline and all follow-up visits to the end of the study.
Time to diagnosis
Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.
Measure resource use
Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study.
Cost effectiveness of LiverMultiScan
Cost of LiverMultiScan based on randomised comparison.
Personnel skills required for diagnosis
Percentage of total consultations performed by a specialist, at each specialist medical category, from date of randomisation to end of study.

Full Information

First Posted
September 5, 2017
Last Updated
August 21, 2023
Sponsor
Perspectum
Collaborators
University of Coimbra, University Hospital Ulm, Leiden University Medical Center, Liverpool University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, King's College Hospital NHS Trust, NHS Greater Glasgow and Clyde, Glasgow Royal Infirmary, Ninewells Hospital, Royal Infirmary of Edinburgh, St George's University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03289897
Brief Title
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
Acronym
RADIcAL1
Official Title
Non-invasive Rapid Assessment of Non-alcoholic Fatty Liver Disease (NAFLD) Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perspectum
Collaborators
University of Coimbra, University Hospital Ulm, Leiden University Medical Center, Liverpool University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, King's College Hospital NHS Trust, NHS Greater Glasgow and Clyde, Glasgow Royal Infirmary, Ninewells Hospital, Royal Infirmary of Edinburgh, St George's University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several European countries.
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is a condition associated with obesity, insulin resistance and heart disease. Research has shown that fatty liver (steatosis) can lead to a spectrum of diseases including low grade inflammation (steatohepatitis or non-alcoholic steatohepatitis (NASH)), cirrhosis or liver failure. The current method used to diagnose liver dysfunction and failure is with percutaneous liver biopsy. This is painful and is not without risk, as the liver is a highly vascular organ. Even with ultrasound guidance, it carries a 1:1000 risk of serious adverse events (e.g. bleeding, infection, bowel perforation). As a result of these factors, liver biopsy is not used in all patients with suspected NAFLD/ NASH unless moderate to severe liver disease is presented or other liver disease need to be excluded. Various diagnostic pathways have arisen, but in the absence of a clearly non-invasive discriminatory test that can stratify normal liver, simple steatosis, steatohepatitis and cirrhosis, there is no standardised pathway. LiverMultiScan has been tested against liver biopsy and has been shown to be the first imaging test that can identify early liver disease and predict clinical outcomes accurately. LiverMultiScan has recently been CE-Marked and FDA-cleared, so is available for clinical use, but as a new test, it is not yet widely established in clinical practice. This study will utilise LiverMultiScan and see if it can be the basis of a viable diagnostic pathway in EU healthcare systems by adopting it in different EU countries, and determining the economic costs and benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis, NAFLD, Metabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
801 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Arm-LiverMultiScan
Arm Type
Experimental
Arm Description
Patients will be scanned using the LiverMultiScan. Follow-up will be determined by the results of the scan.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard of care as per guidelines of the local centre
Intervention Type
Diagnostic Test
Intervention Name(s)
LiverMultiScan
Intervention Description
LiverMultiScan is an imaging technique which is able to identify early liver disease.
Primary Outcome Measure Information:
Title
To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost-effective method in different EU territories.
Description
Proportion of patients with suspected NAFLD incurring liver related hospital consultations and/or liver biopsies, from the date of randomisation to the end of the study follow-up.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient satisfaction: questionnaire
Description
Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study.
Time Frame
1 year
Title
Certainty of diagnosis
Description
Certainty of diagnosis is defined as binary (yes/no vs. unlikely/probable) at baseline and all follow-up visits to the end of the study.
Time Frame
1 year
Title
Frequency of diagnosis
Description
Frequency of diagnosis is defined as binary (yes/probable vs. no/unlikely) at baseline and all follow-up visits to the end of the study.
Time Frame
1 year
Title
Time to diagnosis
Description
Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit.
Time Frame
1 year
Title
Measure resource use
Description
Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study.
Time Frame
1 year
Title
Cost effectiveness of LiverMultiScan
Description
Cost of LiverMultiScan based on randomised comparison.
Time Frame
1 year
Title
Personnel skills required for diagnosis
Description
Percentage of total consultations performed by a specialist, at each specialist medical category, from date of randomisation to end of study.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients aged 18-75 years, due to undergo evaluation for suspected non-alcoholic fatty liver disease Presence of: elevated liver function tests (ALT, AST or GGT ≥ 1.5 x upper limit of normal and ≤ 5 x upper limit of normal) OR imaging suggestive of Fatty liver disease. OR Presence of ≥ 3 of the following criteria: insulin resistance or type 2 diabetes mellitus obesity (BMI > 30 or waist-to-hip ratio > 1.00 for men / > 0.85 for women) hypertension (≥ 130/85 mmHg) elevated triglycerides (≥ 1.7 mmol/l) low HDL-cholesterol (< 1.05 mmol/l for men / < 1.25 mmol/l for women) Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia). Patients with proven liver disease other than NAFLD. Liver transplantation Patients that present with clinical signs of chronic liver failure (variceal bleeding, ascites, overt encephalopathy) Pregnancy Alcohol over-use/ abuse as determined by local guidelines Patient with known malignant liver tumours and those with any malignancy with life expectancy < 36 months Heart failure NYHA stages II-IV Severe mental illness Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Dollinger, MD
Organizational Affiliation
University Hospital Ulm
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitar Tonev, MD
Organizational Affiliation
Perspectum Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
South Holland
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
University of Coimbra
City
Coimbra
State/Province
Centro
ZIP/Postal Code
3004-531
Country
Portugal
Facility Name
Southampton University Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Aintree Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD2 1SG
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G40SF
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW170Q2
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24036007
Citation
Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12.
Results Reference
background
PubMed Identifier
26471505
Citation
Pavlides M, Banerjee R, Sellwood J, Kelly CJ, Robson MD, Booth JC, Collier J, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 2016 Feb;64(2):308-315. doi: 10.1016/j.jhep.2015.10.009. Epub 2015 Nov 10.
Results Reference
background
PubMed Identifier
33104014
Citation
Tonev D, Shumbayawonda E, Tetlow LA, Herdman L, French M, Rymell S, Thomaides-Brears H, Caseiro-Alves F, Castelo-Branco M, Ferreira C, Coenraad M, Lamb H, Beer M, Kelly M, Banerjee R, Dollinger M; RADIcAL1. The Effect of Multi-Parametric Magnetic Resonance Imaging in Standard of Care for Nonalcoholic Fatty Liver Disease: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2020 Oct 26;9(10):e19189. doi: 10.2196/19189.
Results Reference
derived

Learn more about this trial

Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan

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